Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors

Conditions

• Malignant Tumor
• Metastatic Malignant Solid Neoplasm
• Metastatic Solid Tumor
• Unresectable Malignant Solid Neoplasm
• Unresectable Solid Tumor

Eligibility Criteria

Sex

ALL

Age

15 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Electronic Health Record Review — OTHER
  Ancillary studies
• External Beam Radiation Therapy — RADIATION
  Undergo standard palliative EBRT
• Questionnaire Administration — OTHER
  Ancillary studies
• Spatially-fractionated Radiation Therapy — RADIATION
  Undergo SFRT

Study Details

This clinical trial evaluates whether adding spatially fractionated radiation therapy (SFRT) to standard palliative external beam radiation therapy (EBRT) improves disease-related symptoms in patients with solid tumors that cannot be removed by surgery (unresectable). SFRT, originally termed GRID therapy, is a radiation therapy technique designed to deliver a highly uneven dose of radiation to a tumor. This is achieved by using a grid-like pattern, where isolated regions receive high doses, while the spaces between experience significantly lower doses. This method allows for a greater total dose to be delivered to the tumor while potentially reducing damage to surrounding healthy tissues. EBRT is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Adding SFRT to standard palliative EBRT may improve disease-related symptoms such as pain, difficulty breathing, bleeding, or difficulty swallowing in patients with unresectable solid tumors.

Key Dates

First listed

Oct 2, 2026

Start date

Sep 23, 2026

Status verified

Oct 2026

Primary completion

Sep 30, 2031

Completion

Sep 30, 2031

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I (SFRT, EBRT)
  Patients undergo a single fraction of SFRT. Starting 1-3 days after SFRT, patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.
• Active Comparator: Group II (EBRT)
  Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician.

Primary Outcome Measure

Response at 1 month - Patient-reported Impression of Change [ Time Frame: Baseline to 1 month follow-up ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]

Locations (2)

Find similar trials in Scottsdale, AZ

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